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NCT06719440 | NOT YET RECRUITING | Glioblastoma


Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume
Sponsor:

Saint-Luc university clinics- Catholic University of Louvain

Brief Summary:

The objective of the BELGICA trial is to evaluate if radiotherapy could be given in a more focused manner in patients with glioblastoma in order to reduce side effects and improve quality of life. The glioblastoma (GBM) is the most common and aggressive tumour originating from the brain, affecting approximately 600 patients per year in Belgium. The treatment consists in surgical resection of the tumour (when feasible), followed by a combination of radiotherapy and chemotherapy. Despite multimodal treatment (surgery, radiotherapy, and chemotherapy), the life expectancy of patients with GBM remains limited, with an average survival of 12-18 months and only 5% of patients surviving more than 5 years. In addition to limited survival, most patients with GBM experience impaired quality of life, both because of the disease and treatments. Radiotherapy is a treatment where radiation is used to kill cancer cells. In GBM, radiotherapy is targeted at the tumour (or tumour bed if the tumour was resected) with a safety margin around it (the "Clinical Target Volume" or CTV) to account for potential microscopic spread of the tumour. The downside of this safety margin is that a substantial amount of brain tissue is irradiated, which can lead to treatment toxicity. Reducing the CTV margin would enable to decrease the volume of brain being irradiated and could thereby allow to reduce the side effects of brain irradiation. The BELGICA trial (Achieving a BEtter outcome through Limiting the GlIoblastoma Clinical tArget volume) is a national multicentre trial which will evaluate if reducing the irradiation volume in glioblastoma is safe and allows for lowering side effects and improving quality of life.

Condition or disease

Glioblastoma

Radiotherapy Side Effect

Intervention/treatment

Radiotherapy (CTV=10mm)

Radiotherapy (CTV=15mm)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 347 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Impact of Reducing the Irradiation Volume on Survival, Toxicity, and Quality of Life in Patients With Glioblastoma Treated With Radiochemotherapy: a Prospective Multicenter Randomised Study
Actual Study Start Date : 2025-05-12
Estimated Primary Completion Date : 2031-10
Estimated Study Completion Date : 2031-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Participants capable of giving informed consent
  • * Age \>= 18 y.o.
  • * WHO performance status 0-2
  • * Newly diagnosed glioblastoma (Histologically proven glioblastoma per WHO 2021 classification based on biopsy or resection )
  • * Indication of chemoradiotherapy confirmed by multidisciplinary tumour board
Exclusion Criteria
  • * Participation in a competing trial
  • * Known contraindication to undergo MRI scans

Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume

Location Details

NCT06719440


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Belgium,

OLV AZorg

Aalst, Belgium, 9300

Not yet recruiting

Belgium,

Epicura

Baudour, Belgium, 7331

Not yet recruiting

Belgium,

Saint Jan

Brugge, Belgium, 8000

Not yet recruiting

Belgium,

Saint-Luc university clinics

Brussels, Belgium, 1200

Not yet recruiting

Belgium,

Institute Jules Table

Bruxelles, Belgium, 1070

Not yet recruiting

Belgium,

Already brussel

Bruxelles, Belgium, 1090

Not yet recruiting

Belgium,

Hospital East Limburg (ZOL)

Genk, Belgium, 3600

Not yet recruiting

Belgium,

The Sint-Lucas

Gent, Belgium, 9000

Not yet recruiting

Belgium,

To Gent

Gent, Belgium, 9000

Not yet recruiting

Belgium,

Large Charleroi Hospital

Gilly, Belgium, 6060

Not yet recruiting

Belgium,

Jessa Hospital

Hasselt, Belgium, 3500

Not yet recruiting

Belgium,

AZ Groeninge

Kortrijk, Belgium, 8500

Not yet recruiting

Belgium,

chu helora

La Louvière, Belgium, 7100

Not yet recruiting

Belgium,

UZ Leuven

Leuven, Belgium, 3000

Not yet recruiting

Belgium,

CHU Liège

Liège, Belgium, 4000

Not yet recruiting

Belgium,

AZ Sint Maarten

Mechelen, Belgium, 2800

Not yet recruiting

Belgium,

André Vésale Hospital - Humani

Montigny-Le-Tilleul, Belgium, 6110

Not yet recruiting

Belgium,

CH Mouscron

Mouscron, Belgium, 7700

Not yet recruiting

Belgium,

Chu UCL Namur - Sainte Elizabeth

Namur, Belgium, 5000

Not yet recruiting

Belgium,

The delta

Roeselare, Belgium, 8800

Not yet recruiting

Belgium,

Europe clinics

Uccle, Belgium, 1180

Not yet recruiting

Belgium,

Chr Verviers

Verviers, Belgium, 4800

Not yet recruiting

Belgium,

Zas Augustine

Wilrijk, Belgium, 2610

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